Savara Inc (NASDAQ: SVRA) was one of the biggest gainers in yesterday’s trading session, closing the day with gains of 183.82%. This came after the company announced that, the FDA had granted it Breakthrough Therapy Designation for Molgradex. Molgradex is an inhaled formulation of human GM-CSF (Granulocyte-Macrophage Colony-Stimulating Factor) for treating APAP.
Breakthrough Therapy Designation entails giving the leeway for the development and review of a drug that is meant to treat serious illnesses and which, early clinical evidence shows improvement over existing therapies. In this context, the breakthrough therapy designation is based on data obtained from IMPALA. This is Savara’s phase 3 clinical study for treating APAP. The company recently presented data on this study during an oral session at the 2019 European Respiratory Society (ERS) International Congress. It was held in Madrid, Spain.
Commenting on the breakthrough, the company CEO, Rob Neville stated that, they were happy that the FDA had recognized the treatment as a breakthrough therapy for treating APAP, a rare lung disease that doesn’t have any approved treatments at the moment. He added that, the company believed the designation reflected the significance of Molgradex based on the IMPALA study, as it had been shown to improve outcomes for patients. On top of that, the CEO stated that, breakthrough designation opens the door or more collaboration and more dialogue with the FDA, and was a major milestone as the company seeks the best strategy for the product.
On the 20th of December 2019, the company announced that it had entered into a private placement with institutional investors to buy a total of 9,569,430 shares at $1.745 per share. It’s management stated that, it would use money from the sale to fund a new clinical trial for Molgradex.
From a look at its price action, the company traded between a low of $4.91 and a high of $5.20 before closing the day at $4.91. Volumes in the day stood at 55.62 million.
About Savara Inc
Savara Inc is a biopharma company that focuses on orphan lung diseases. It is based in Austin, Texas.